BEUDAMED
    FDA Enforcement Class II Terminated

    Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

    Recall: Z-1010-2019 · Reported March 20, 2019

    Enforcement

    Recall Number
    Z-1010-2019
    Event ID
    82099
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 20, 2019
    Initiation Date
    December 17, 2018
    Classification Date
    March 12, 2019
    Termination Date
    November 18, 2020
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

    Reason

    The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.

    Code Info

    Serial Number 2506043 and 2619818

    Distribution

    US Nationwide distribution in the states of CT, IL, MN, MO, and NC.

    Quantity

    2